Wednesday 23 April 2014

EU GMP Annex 15 Revisions: Improving Qualification and Validation

Annex 15 of the EU GMP guide is concerned with the ‘Qualification and Validation’ of pharmaceutical facilities, addressing requirements for equipment, utilities and processes that are used for the manufacture of medicinal products. The broad requirement of Annex 15 is that a pharma manufacturer needs to identify what qualification and validation work is required; next, the manufacturer must prove that critical aspects of work are controlled; and finally, the key elements of qualification and validation need to be defined and documented.

Validation and qualification form an important part of the quality system in the pharmaceutical sector and can be defined in different ways. Tim Sandle, Head of Microbiology, BPL, UK discusses some standard definitions from a Good Manufacturing Practice (GMP) perspective.

The article has been published in the current edition of Cleanroom Technology.

The reference is:

Sandle, T. (2014) EU GMP Annex 15 Revisions: Improving Qualification and Validation, Cleanroom Technology, April 2014, pp14-16

If you are interested in reading the article, please contact Tim Sandle

Posted by Tim Sandle

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